OHSU

Select Agents/Toxins

What do I do if I have a select agent in my laboratory or have questions about select agents?

OHSU must register with and be certified by the CDC and/or USDA if any individuals working in an OHSU facility possess, use or transfer select agents. If you currently possess (or are considering the use of) a select agent please contact one of the Responsible Officials (ROs):

OHSU Main Campus Biosafety Officer, (503) 494-0655, or OHSU West Campus Biosafety Officer, (503) 690-5312 or send us an

What is a select agent or toxin ("select agent")?

A listing of HHS select agents and toxins in the new select agent regulation (42 CFR 73) is available at http://www.selectagents.gov/Select Agents and Toxins list.html


What is excluded from the new select agent regulation (42 CFR 73)?

The following are excluded from the regulation:

  • Select agents or toxins that are in their naturally occurring environment, provided that it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
  • Non-viable select agent organisms or nonfunctional toxins.
  • Specific strains or toxins that are attenuated and determined not to pose a significant public health or safety threat. Exluded strains are listed on the Select Agent website: http://www.selectagents.gov/Select Agents and Toxins Exclusions.html

    Exclusions for entities with specific quantities of toxins under the control of a principal investigator at a given time are also detailed in the regulation.

 

Toxins are regulated based on potency and quantity (as opposed to potency only or LD50 values as in 42 CFR 72.6). Entities that do not at any time have more than the following aggregate amounts (in the purified form or in combinations of pure and impure forms) under the control of a principal investigator are excluded from requirements of the regulation:

Abrin

100 mg

Botulinum neurotoxins

0.5 mg
Short, paralythic alpha conotoxins

100 mg

Diacetoxyscirpenol (DAS)

1,000 mg

Ricin

100 mg

Saxitoxin

100 mg

Staphylococcal Enterotoxins(Subtypes A,B,C,D and E)

5 mg

Tetrodotoxin

100 mg

T-2 toxin

1,000 mg


Attenuated strains of HHS select agents and toxins excluded:

  • Yersinia pestis strains (e.g., Tjiwidej S and CDC A1122) devoid of the 75 kb low-calcium response (Lcr) virulence plasmid. (effective 2-27-2003 Background 

Attenuated strains of Overlap select agents and toxins excluded:

  • Bacillus anthracis strains devoid of both plasmids pX01 and pX02. (effective 2-27-2003) Background
  • Bacillus anthracis strains devoid of the plasmid pX02 (e.g., Bacillus anthracis Sterne, pX01+pX02-). (effective 2-27-2003) Background
  • Francisella tularensis subspecies novicida (also referred to as Francisella novicida) strain, Utah 112 (ATCC 15482). (effective 2-27-2003) Background
  • Francisella tularensis subspecies holartica LVS (live vaccine strain; includes NDBR 101 lots, TSI-GSD lots, and ATCC 29684). (effective 2-27-2003) Background

For additional reference, including links to the select agent regulation text and additional FAQs, please see: http://www.cdc.gov/od/sap/index.htm